Medical Device Recall: Z-0040-06

FDA Recalls dataset · Firm: Boston Scientific Corporation · Status: Terminated

Recall Action Class: N/A Date Initiated: 2005-09-23 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0040-06.

Recall Res Number
Z-0040-06
Recalling Firm / Manufacturer
Boston Scientific Corporation
FEI Number
3001451463
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2005-09-23
Date Posted
2005-10-28
Date Terminated
2006-10-24
Product Code
LNM
Event Number
33529
Product Quantity
M00572600 =7844 kits ;M00572500=859 kits
Product Description Enteryx Procedure Kit Order No.: M00572600 -US and M00572500 -OUS
Reason for Recall Incorrect implantation may cause serious health complications
Action Details Boston Scientific issued Recall notification by FED'X on 9/23/05 as follows Customers/ Hospital Account / Distributors: A Recall Notification Package will be sent to the risk manager of each hospital account via FedEx. This package contains a Recall Notification Letter, instructions on how to return product, a Recall Verification Form, and a Physician Letter that provides recommendations of patient follow-up. . Physicians Trained in the Enteryx Procedure: All physicians that attended the physician training program sent, via FedEx, a Physician Letter notifying them of the voluntary recall and providing them with firm recommendations on patient follow-up. In addition a copy of the Patient Letter and Patient Phone Script will be provided to assist in their communication to the patient. Patient Letter / Patient Phone Script: A letter and phone script, from the physician to the patient, will be provided to the physician to assist in the physician's communication to patient. The letter informs the patient of the recall and asks them to contact their physician and the Patient Phone Script provides a template to initiate a discussion with the patient. Physicians Participating in Post Approval Studies: All physicians that are participating in post approval studies will be sent, via FedEx, a Physician Letter notifying them of the voluntary recall and providing them with firm's recommendations on patient follow-up. In addition a copy of the Patient Letter and Patient Phone script will be provided to assist in their communication to the patient. Internal Review Boards (IRBs): All IRBs that are participating in post approval studies will be sent, via FedEx, a IRB Letter and the Physician Letter notifying them of the voluntary recall and providing them with firm's recommendations on patient follow-up. In addition a copy of the Patient Letter and Patient Phone Script will be provided. Boston Scientific has posted the recall to their website:http://www
Distribution Pattern Nationwide :
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